A Feasibility Study of Supplemental Oxygen to Improve Pulmonary Hypertension in People With Intradialytic Hypoxemia (SOPHIE)

August 26, 2025 updated by: Duke University
The purpose of this study is to assess the feasibility of supplemental oxygen delivery during hemodialysis in people with pulmonary hypertension and intradialytic hypoxemia.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

10

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27701
        • Davita Durham East
      • Durham, North Carolina, United States, 27703
      • Durham, North Carolina, United States, 27703
      • Durham, North Carolina, United States, 27704
      • Durham, North Carolina, United States, 27705
      • Durham, North Carolina, United States, 27707
      • Durham, North Carolina, United States, 27713
      • Durham, North Carolina, United States, 27713
      • Henderson, North Carolina, United States, 27536
      • Henderson, North Carolina, United States, 27537
      • Roxboro, North Carolina, United States, 27573

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adults ≥18 years
  • Receiving Monday-Wednesday-Friday or Tuesday-Thursday-Saturday hemodialysis
  • Screened positive for pulmonary hypertension (defined by tricuspid regurgitant velocity [TRV] >2.5 m/s on echocardiography) and intradialytic hypoxemia (defined by spending ≥1/3 treatment with O2 saturation <90%) or hypoxemia for ≥10% of the treatment if associated with a desaturation event (≥4% decline in O2 saturation to <88% for ≥10 seconds) during enrollment in the PH-ESKD study (Pro00108710).

Exclusion Criteria:

  • Daily supplemental oxygen use
  • Inability to provide informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Room air
Participants will receive no supplemental oxygen.
Drug: Room air
Room air without oxygen concentrator
Experimental: Supplemental oxygen (0.5 liters per minute)
Participants will receive supplemental oxygen by oxygen concentrator delivered by nasal cannula at 0.5 liters per minute.
Drug: Oxygen
Supplemental oxygen by oxygen concentrator
Experimental: Supplemental oxygen (3 liters per minute)
Participants will receive supplemental oxygen by oxygen concentrator delivered by nasal cannula at 3 liters per minute.
Drug: Oxygen
Supplemental oxygen by oxygen concentrator

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change daily hypoxemia burden
Time Frame: Weeks 1, 2, and 3
Minutes with oxygen saturation <90% over a 24-hour period assessed by pulse oximetry
Weeks 1, 2, and 3

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in six minute walk distance
Time Frame: Weeks 1 and 3
Scores are measured as meters walked during a six-minute assessment
Weeks 1 and 3
Change in Montreal Cognitive Assessment (MoCA)
Time Frame: Weeks 1 and 3
Scores are measured on a 30-point scale
Weeks 1 and 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Investigators

  • Principal Investigator: Daniel Edmonston, MD, MHS, Duke University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

June 30, 2027

Study Registration Dates

First Submitted

March 18, 2024

First Submitted That Met QC Criteria

March 18, 2024

First Posted (Actual)

March 25, 2024

Study Record Updates

Last Update Posted (Estimated)

August 27, 2025

Last Update Submitted That Met QC Criteria

August 26, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00114903

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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